Category Archives: Quality

Quality Management, does a certificate help?

Previously we touched upon whether or not a certificate is worth it. This post led to quite some discussion, with strong opinions from both sides. However, looking at Quality Management in general you can ask the question, “Does a certificate add value, and if so, how?”

As you might know, we believe Quality Management is important for everybody in the company. Every person has an influence on the Quality of the product or service the company produces. But to do this, is a certificate required other than a customer requirement? Lots of companies deliver high-quality products, but most of them are not certified.


Of course, a certificate is not required to produce high-quality products. Every company that has a great focus on Quality will be able to produce high-quality products and services regardless. The people in the organisation mainly determine quality, not by the certificate. However, the certificate can give a certain kind of guidance and structure that can help a lot. There are certain things that need to be formalized, such as continuous improvement. Having the Management System audited on a regular basis puts back the focus on it. In the end, it all depends on how the management system is set up and how the employees use it. Nevertheless, there are always industries where you simply cannot operate without the certificates.


A standard forces a certain structure in the Management System. Yes, with most standards, you have quite some freedom on how to set up the Management System, but there are certain requirements for a company to work accordingly. A great example is the focus on continuous improvement. These can feel rigid in a way but they also give a great framework when you are trying to get some kind of structure in the organization. This structure can also work great as a playbook for expansion when the company wants to keep a certain level of Quality throughout different branches in different parts of the world.

Force for Change

In every company, there is room for improvement. However, convincing people to move and change the way they work isn’t easy. An advantage of having an auditor coming in every year is that as a Quality Manager, you can leverage them to force internal change. When speaking with hundreds of Quality Managers, we hear over and over again that they do this. However, when you use this tactic, never tell the people that the auditor is forcing this change, as this will not go very well. Not being certified makes it harder or even impossible to use this practice.


At the end of the day, a certificate isn’t really required, but it can help the company quite a lot in structuring the Quality Management within the company. Also, the external audits can be some kind of leverage to create change.

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Quality can sometimes feel ungrabbable

Quality can feel immeasurable sometimes. By immeasurable, we don’t mean all the KPIs we defined within our management system. We have great KPIs to measure company performance, which include things like:

  • Customer satisfaction
  • Production fail rates
  • Recalls
  • Costs of Quality

We say Quality is immeasurable more in the sense of soft output—things like how Quality culture is and how our employees see their work in relation to Quality.

Measuring Quality

Quality Controls in production environments are crystal clear, it either falls within range or doesn’t. If the product doesn’t fall within acceptable levels, it will be rejected. However, Quality Control in more interpersonal activities is much harder to measure. How do you rate the support of a company, for example? Not picking up the phone is a clear bad sign, but the tone of voice of the employee can also have a big impact. Especially the service departments of companies face these interpersonal complexities. Companies and business gurus came up with all kinds of measuring tools to get a good feeling about this, but the fallacy is still embedded in it. What if the person on the other end of the phone is just having a bad day? We cannot easily compensate for this other than in a statistical way. Also, most of these methodologies are making use of the average from lots of data, which is great, but doesn’t say anything on individual cases. Just measure the things that are important and acknowledge that there is bias in the data. And always check for the biggest impact, not only the average of all the data.

Outside Process

To make it even more complex, there are certain outsourced processes that also have a significant impact on the quality perception of the customer. A great example is the delivery guy/girl that delivers the packages for your company. He or she just drops the package over the fence without much care or wasn’t able to deliver it. The customer would get annoyed at the company while you weren’t able to complete control the process. Yes, again, there are ways to measure suppliers, but there is no way for the company to control this process because there are no internal resources for this. In order to have a good feeling of control, make sure critical suppliers are regularly audited and allow customers to easily file a complaint on your website. Use this data to manage and control the outsourced processes. This gives at least some form of control.


Get comfortable with having these immeasurable and hard to define KPIs within the company. There will always be certain outputs that are hard to measure; just make sure there is clear guidance within top management, as well as within the workforce, on how to perceive them. Getting the Quality mindset adopted throughout the company will ensure a much better feeling on the Quality within the company. Create measurable KPIs where possible to back things up with data.

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Integrate Quality in Your Company Strategy

Quality is a key pillar in every organization. When a company delivers inferior Quality, it will be out of business quite soon. Hence, maintaining high-quality products and services is very important. However, getting Quality Management deeply embedded in the organization isn’t always easy. Everybody within the organization needs to understand his/her impact on the Quality and, more importantly, the perception of Quality of the customer. Quality should be embedded in every part of the business to truly deliver the best Quality possible.

Quality Consistency

Especially when the organization gets larger and more people are involved in the products and services, maintaining consistent Quality levels can become hard. This is when having a clear vision of what Quality means to the company becomes essential. Creating this vision should not be simply handed over to the Quality Manager—this is a job for Top Management. A properly functioning Quality Management System is critical in this. Having more people touching the product and/or service means that there is more room for inconsistencies. We are all human, so we will not deliver constant Quality, which is fine. As an organization, it is important to keep the minimum Quality level steady, regardless of who is doing the job. This is guaranteed by creating proper Quality checks.

Top Management 

The involvement of Top Management in the strategy is one of the most critical aspects. Top Management has to show their dedication and focus on Quality within the organization. Getting this involvement isn’t always easy, but with some techniques, this is doable. Some great tips are:

  • Using data to show Top Management how Quality performs
  • Show how customers value the Top Quality
  • Show the costs of not having Quality 

These are just a few points to use, but there is much more. The type of indicators come from anywhere in the company: logistics, production, sales or HR. This clearly shows that Quality is embedded in every part of the company. The exact triggers are, of course, also dependent on the personality of the people in Top Management. Make sure you communicate with them in a way that is in line with their personality.

Employee Involvement

Yes, Top Management involvement is critical, but without involvement from the employees, Quality Management isn’t working either. The employees are the people that do the job and see when things are going right or wrong. They are crucial in having a Quality Culture. They need to look at everything they do through Quality glasses, which will really increase the overall Quality. Never ever forget to make them part of the Quality strategy and translate the Quality to clear things they need to do.

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What Really Matters in QHSE Management

My days as a QHSE Manager are long gone, now I am lucky to be able to help many more companies than I could ever imagine. Every day, we help companies to push much further than simple compliance. Quality, Safety, and Security are about so much more than just compliance. Yes, compliance is an important component, but a company can get so much more out of a proper working management system.

Safety Is Everything

Safety should come before anything else. You can simply not do anything when people get injured all the time. Eventually, you will be left with nobody to do the job. The business reasons aside, we have a duty to everybody to make sure people leave through the door the same way they arrived. This has nothing to do with compliance perse, but just good moral and business practices.

With this in mind, safety should be practical as well. We hire professionals or train people to become professionals. Please trust them a little bit. Only intervene when things are getting out of hand and try to grow a sense for people that are slacking.

Quality Is Everything

Quality is not just the product or service produced or delivered by the company. Quality is everywhere from the marketing material, packaging, employees, and customers to even the way you handle leaving customers. It doesn’t have to be perfect, but the Quality should be great and the experience should be even better. Not everything will go according to plan, but make sure the customer is informed and knows what is going on. Try to make these bad experiences as painless as possible.

In essence, this has nothing to do with compliance to begin with, it is just good business. The Quality standards (ISO9001/IATF16949/IS13485) are merely guidelines. As a company, you should strive to do the best you can, regardless of the applicable standard.

Security Is Everything

In today’s highly connected world, digital security should be an incorporated part of the management system. Even if the company isn’t certified for any standard, it is crucial to take the necessary steps in order to prevent a breach. Ransomware costs billions every year and up to 8 billion dollars globally. Having a proper security program in place is critical, especially for non-IT companies. It still happens too often that people click on a link or PDF without knowing the sender.

Again, the 8 billion spent on Ransomware has nothing to do with compliance. You need to make sure the company is ready and resilient to these matters, whether you are certified or not.


The certification, whether it is ISO9001, ISO14001, ISO45001, or ISO27001, is merely a framework. In the end, almost all the compliance topics boils down to culture. Some people might say, “It is not important” or “Don’t bother me with this”—but they don’t really get it. As a Quality/Safety/Compliance manager it is your duty to make them see the importance. It is not your job to do all the tedious tasks, those should be done by the responsible person. You should guide them, train them, and make them aware. A culture is created by everybody in the organization and the stakeholders close it. But it is your job to make Safety, Quality, and Security a part of the culture.

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Quality 4.0, What Is It?

There have been thousands of articles written about Quality 4.0 in various contexts and for various industries. Some claim that you should gather information, make the SOP digital available and train employees via e-learning. Yes, you should do all of this but that was part of Quality 3.0, not 4.0. If your company hasn’t moved to a Quality Management Cloud Platform, you are not ready for Quality 4.0, unfortunately.

So before you start to even think about a Quality 4.0 strategy, make sure you have a good foundation. You simply cannot try to execute the strategy without a proper QMS Cloud platform. You need to have the infrastructure to gather the data, connect the data and analyze the data. The implementation of the Quality 4.0 strategy can take years, so make sure the platform is able to adapt to changes in the market and allows for adjustment.

Data Is Key

Quality 4.0 is mainly about leveraging a significant amount of data to increase the Quality of the products and services produced. This sounds pretty straightforward because we crunch data every day, but having the right data is actually quite difficult. Most companies do have data, lots of data. However, when they start analyzing it they see big missing chucks, inconsistent data and simply corrupted data.

Having machines that are able to share their data, easy-to-use interfaces to create valuable data and other sensors and IoT solutions that generate data are essential sources. To further enrich your internal data, it is possible to buy datasets from bit Data Management Platform provider. These external sets can be used to benchmark your internal data or find context. The data needs to be vast, but more importantly accurate, so make sure data quality checks are in place to ensure this. In the end, wrong data can lead to wrong conclusions.

Connecting the Dots

When you really want to make sense of the data you are harvesting, it is important to connect it all. When going the Quality 4.0 route, open platforms and systems are key. It should be possible to connect the different systems and platforms with each other without much effort. This way data can easily flow between the systems and they can make sense of it for their particular purpose. The machine data can be used to predict production problems in a badge by the QMS platform. The same data can be used to plan predictive maintenance by the Asset Management platform while the ERP uses it to bill the customer. A single source of data can be interpreted and used in several different ways by different solutions so make sure it flows easily. This is why it is essential to allow for integration between different solutions and platforms.

The important component is that the data should be accessible to multiple departments. Different departments can leverage data in different ways as described by how the machine data can be used. In order to make the data accessible and interpretable for different departments, great BI tools are key. These are the platforms that visualize the data and give them more context to the people.

Make sure the data is not only accessible to management but make it visible to every layer in the company. This will get them informed but also engaged in the performance of the company. Quality 4.0 is not only digital and data, the main component is still and will always be the people.

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Quality as a driver for Growth

Quality Management is regularly seen as a cost center. The organization may have the feeling they need to shell out a significant amount of money to set up a Quality Management System and get it off the ground. Then when a certificate is required in order to prove that the QMS somehow functions, more money is needed. This perception is a big struggle for Quality departments all around the world, even though the facts are different. Quality is actually a true profit center if it is done correctly and genuinely incorporated into the fibers of the organization. This is because high-quality products and services are a key driver for added value and business growth. Creating and maintaining a high level of quality should, therefore, be a top priority to everybody in the organization.

Quality as Your Differentiator

The Quality of the products and services is the number one differentiator a company has. Having superior quality products and services will give the company a head start over any of its competitors. With this we mean Quality in the broadest sense of the word—from the first interaction with the sales team to the continuous interaction with the service team and everything in between. When this experience is world-class, people will come back and retaining an existing customer is so much easier than developing new ones all the time. Besides, the market will see the superiority of the products and services and companies want to do business without much effort. Hence when the Quality is high class and above expectation it will become a big driver for growth. This is very different than the cost center as some companies look at it.

The Quality Management System

To be honest, it is at the QMS level where the discrepancy between Top Management and operation starts to happen and where the problems start. Passionate Quality Professionals incorporate the standards in the QMS, which leads to quite some procedures. On the other hand, Top Management, as well as a number of employees, just see a bunch of required documents and procedures without much added value. They have the feeling the QMS is mostly created to please the auditors and not to have the quality in mind, let alone help them. However, these procedures and policies are designed to maintain the high level of Quality the company is striving for. It is crucial to articulate this clearly; leaving out any reference to the standards will be a good start. Next to that, keep talking about the added value of maintaining the Quality. Explain that the checks and balances such as audits and quality checks are created to maintain the Quality of the products and services, not to bother them. This is well known by us Quality professionals but it is not in the heads of Top Management. It is our job as Quality Professionals to get it there and show how the business can reach growth thanks to it.

Make It Measurable

When making compelling arguments to Top Management but also to other employees, it is essential to have data to back up claims. Data such as customer satisfaction, referrals from current customers, services call reductions, recall reductions, production error reductions, etc. When using data it is important to put them into perspective for Top Management. When, for example, production errors went up by 10 percent but production itself went up by 50 percent, the 10 percent isn’t really that bad. In this case it is better to make use of ratios. For numbers such as referrals from existing companies, they can be presented as they are. This also shows that it is important you get this data and you get involved in the sales organization as well to make sure you can trace back these referrals.

In Quality we might not impact the numbers directly but we create the road for others to excel and growth for the business.

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The Importance of Procedures and Processes

The introduction of the new ISO 9001: 2015 a couple of years back set off a widespread belief that companies don’t really need procedures anymore. We have seen companies cutting down their procedures, some by around 60 to 70 percent. For some Quality Management Systems this was a good thing, but many companies found out that they actually needed the procedures to have some form of guidance in the organization. These companies have been reintroducing the binned procedures into the organization.


Let’s start with the definition of procedure. We always define it as:

“Documents that describe how the company operates.”

Procedures can be all kinds of documents from processes to work instructions and safety procedures. We use this broad definition because these are the documents that describe how the company operates. These are the documents that describe how the company builds its products or delivers their services.

Getting rid of too much of these documents will make it confusing. Employees should be able to find documents that describe how the company functions and what they should do in the process.


Companies should have some form of documented procedures as reference materials for employees. However, the key is to keep them as concise and clear as possible, a 400-page procedure won’t be read by anybody and therefore isn’t very effective.  Furthermore, procedures are quite important in keeping consistent quality of products and services. You don’t want every employee to have his or her own level of Quality. Documenting this in a procedure or work instruction gives employees clear guidelines on what to do and what others expect from them. The same goes for processes, it is always a good idea to have the core processes mapped out with the related procedures. You don’t really need to document everything in detail, but some documentation is recommended.


This is where the shift to the new ISO 9001:2015 shows some of its power. The process doesn’t have to be documented when it is automated. Automating processes is a great way to get rid of the documents while keeping a certain level of Quality. The process is covered now by the platform and certain steps or data points are now forced. This is the ideal way to take out procedures for auditing, NC management, document control and management review. The other big advance of course is that people have to follow the system so the process is controlled.

Hopefully you didn’t get rid of all the procedures and work instructions, so you can simply put them back in place.

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How a good Quality Management System helps the company.

Everybody in Quality knows that having a functioning Quality Management System will reduce costs. Maybe not the next day, but in the long haul it will make the company money if it is functioning properly—and this is where the real problems lie. A significant number of Quality Management Systems don’t function correctly, either due to a lack of resources or due to a lack of involvement by management. However, when it does function properly, the company can really streamline operations and get a better position in the market.

Lack of Importance

This is probably one of the biggest struggles for Quality Managers. Top Managers may understand the importance of having Quality Standards, but they don’t really understand Quality Assurance and how it can help the bottom line.

Top management isn’t always willing to invest in proper platforms and tools to manage all the data and allow for detailed analysis. They don’t see why the company needs such a platform. They will come up with things like, “we have already an ERP system”. This really shows they need to be educated because an ERP system is not going to help with structuring the QMS and improving the processes.

The Impact

Top management looks at the production rate and how much has been produced over the last month. They look for possibilities to increase the output with the same number of people. Yes, it might be possible to increase the output but it will have an effect on the quality. The issue is that these implications aren’t always instantly clear. Problems might start to occur weeks or months after the products have been delivered to the customer. So for a period of time, it looks like the production increase had a positive impact on the number. However, when the warranty claims start to come in, increasing production might not have been such a great plan.

The point is that a significant number of companies cannot even track these basic numbers, because their QMS isn’t working properly. Warranty claims aren’t properly logged in the QMS which makes it very hard to find this correlation. This is just a simple example but there can be a range of different correlations within your company. The company cannot see the implication of their choices because the QMS is simply ineffective here.

The Importance

Having a functioning Quality Management System in place is important to keep the Quality of products high. In order to really reduce the production costs, some parts are critical in a QMS.

Structured Way of Working

Documenting the ways a company operates is a good technique to get a feeling of what the company actually does and what comes to building the products or providing the services. This can be a process, procedure, work instruction, SOP, etc. It doesn’t really matter how it is called, as long something is documented and easily transferable to a new employee. The documented way of working is crucial in maintaining a certain level of quality within the company. It would be very weird if every employee can decide for themselves on how to assemble a piece of machinery. Make sure these documents are easily accessible and transferable.

Improvement Plans

A proper Quality Management System will harvest data on everything that goes wrong within the company. This data can be leveraged by the Quality Department to come up with improvement plans that are based on facts. This will directly lead to better products, shorter production time, less rework, etc. Having the actual data at the fingertips and being able to track it over time allows the Quality department to measure if the improvement plans actually work or if they need changing. Data-driven improvement plans enable companies to reduce a lot of costs.

Historical Data

Data is, like in most parts of business, key for Quality Management. As touched upon before, having data to correlate issues to change in the production flows allows for finding the root cause for the problems. It also allows for finding correlations during certain seasons. The data is golden for starting off the right improvement plans.

When combining the Quality data with data from other platforms, the company can really start to streamline the organization. Connecting planning data to the Quality data allows for finding correlations between shifts and issues. These things can only be realized when the data is within the company.

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The Outputs of Design and Development Clause 8.3.5

In the previous post we touched upon the inputs for the Design and Development Clause of the  ISO 9001 standard. The outputs are closely related to the inputs of course, but they have some twists to them. The four outputs that need to be covered are:

  1. Meet the input requirements.
  2. Be suitable for subsequent processes for the provision of products and services.
  3. Include, or refer to, appropriate monitoring and measuring requirements and their acceptance criteria.
  4. Define the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

All the information of the Design and Development outputs needs to be documented either through a register or some other form.

Meet the Input Requirements

This one is pretty straight forward. The product should meet the input requirements. If the product or service doesn’t meet the requirements, it isn’t only useless, but we have also failed to fulfill our customer’s needs—a pretty important part of doing business. To meet the requirements, it is critical that these requirements were very clear in the first place. The clarity of the requirements should be well thought of during the input phase of the design and development process.

Be Suitable for Subsequent Processes for the Provision of Products and Services

The company should be able to have processes in place to realize the product or service according to the specs of the customer. These processes are part of the QMS and should lead to a desired output. It should be very clear that the QMS of the company is able to produce the product within specs and rules and regulations.

Include, or Refer to, Appropriate Monitoring and Measuring Requirements and Their Acceptance Criteria

The company needs to have a strong plan to monitor if the product is designed as expected. This can, of course, be accomplished by very close communication with the customers and other stakeholders in the process. The way the company communicates and how it documents this information should be clearly defined to make it unambiguous.

Define the Characteristics of the Products and Services That Are Essential for Their Intended Purpose and Their Safe and Proper Provision

The products or services should function as intended—this is also closely related to the input requirements. When these are pretty clear, it gets a lot easier to make the product or service function as intended. However, even if the requirements are clear, the company should fully understand if the product or service is safe and properly functioning. The customer can request a car without a steering wheel, but even if the company built such a car, it is mostly likely not safe and not intended to operate like this, except for a self driving car maybe. So even if the specs are clear, the company has the duty to judge if the functions are really what some can expect from the product or service. 

Documented Information on Design and Development Outputs Must Also Be Retained—IE: Records

Lastly, it is crucial to have all the information created during the processes documented in some way. This can be in Word/Excel documents or in specialized platforms. It should be retrievable whenever asked for by someone.


The 8.3.5 isn’t all that hard in essence, it just requires the company to make sure that the product is developed as intended by the stakeholders. The information that is created during the process should be registered in a system as per the company’s choice. 

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Bring your quality & safety inspections to the next level

Filling out paper forms is very time-consuming. No one enjoys it, especially when it means a lot of extra work after forms are filled in. Usually the forms have to be checked and re-entered to the quality management system, which means hours of additional work every week—for nothing. Using pre-configured and custom mobile forms, your company can easily save hours of valuable time per inspection.


It’s hard to monitor progress or draw conclusions from a stack of papers. Manually entering data into a spreadsheet or other document and creating reports is time-consuming and carries the potential for human errors, including inaccurate or omitted information.

On the other hand, digital forms are automatically uploaded into your quality management system, where it is compared to existing data. From there it’s easy to track progress, setbacks, health and safety concerns, and other significant events, allowing quality inspectors to easily create impactful reports.

Incident Reports

Digitizing the management system means that on average 30% more incident reports come in. The ease of use lowers the barriers because it makes it easy for employees to fill in digital forms during their inspection walks on their phone or tablet. Besides that, they also have the possibility to attach a picture with a description of the non-conformity. All these processes have been simplified so that incidents are actually reported.

Take Action

After you’ve collected data and identified a potential problem, it’s time to take action. Plan your corrective and preventive action in a proper manner and make them actionable. By directly assigning the action to the responsible person, it becomes much easier to manage the action that resulted from the inspection. With an online quality management platform you can easily track progress on the tasks and analyze their effectiveness.


With Qooling, paper quality and safety inspections are history. The online solution offersyou a simple way to digitize your quality and safety inspections and reduce the dailyworkload. Log in from any location and have real-time insight into the work of your team, anytime and everywhere. Try it today!

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